Tool assembly with minimal dead space

ABSTRACT

A surgical stapling device includes a handle assembly, an elongate body extending distally from the handle assembly, and a tool assembly. The tool assembly includes an actuation sled that is movable through a staple cartridge to eject staples from the staple cartridge and a clamp member that is movable through the tool assembly to move the tool assembly from an open position to an approximated position. In order to minimize dead space in a proximal portion of the tool assembly, the actuation sled and clamp member are supported in a nested relationship in a pre-actuated state of the surgical stapling device. The clamp member is subsequently moved to a position proximal of the actuation sled during a firing stroke of the stapling device.

BACKGROUND 1. Technical Description

The present disclosure is directed to a surgical stapling device and, more particularly, to an endoscopic surgical stapling device including an articulating tool assembly having an assembly including a knife clamp member and an actuation sled.

2. Background of Related Art

Surgical stapling devices for endoscopic use are known and include a tool assembly having a pair of jaws that are movable in relation to each other between open and clamped or approximated positions. Typically, one jaw of the tool assembly supports a staple cartridge having a plurality of staples and the other jaw of the tool assembly supports an anvil assembly. The tool assembly is supported on a distal portion of an elongate body of the surgical stapling device. In known stapling devices, the tool assembly is supported on the distal portion of the elongate body to improve access to tissue within a patient during an endoscopic surgical procedure.

Linear surgical stapling devices for endoscopic use include a drive member that supports a knife and an actuation sled. The actuation sled is positioned distally of the drive member within the staple cartridge and is driven by the drive member from a retracted position to an advanced position as the drive member is advanced through the staple cartridge. The actuation sled is configured to sequentially eject the staples from the staple cartridge as the actuation sled moves towards the advanced position. The jaws of the tool assembly may also include a tissue stop that prevents tissue from being positioned within a tissue gap defined by the pair of jaws at a location proximally of the location of the staples of the staple cartridge. The actuation sled is positioned distally of the knife of the drive member to facilitate formation of the staples in tissue prior to transection of the tissue.

Typically, the drive member includes clamping structure such as an I-beam to move the jaws of the tool assembly from an open position to an approximated or clamped position and to limit the size of the tissue gap defined between the jaws of the tool assembly. In such devices, since the drive member is positioned proximally of the actuation sled and proximally of the tissue stop, a proximal portion of the tool assembly includes a substantial amount of dead space, i.e., space on the tool assembly that is unusable for performing a stapling or cutting operation. In a surgical stapling device having a tool assembly that articulates, the dead space extends from an articulating axis or pivot point of the tool assembly to the tissue stop. This dead space increases the overall length of the tool assembly. The increased overall length of the tool assembly restricts access of the tool assembly to areas within a body cavity during an endoscopic surgical procedure.

It would desirable to minimize the length of the dead space of a tool assembly of an endoscopic surgical stapling device having an articulating tool assembly to provide improved access to tissue within a body cavity of a patient during an endoscopic surgical procedure.

SUMMARY

In one aspect of the disclosure, a surgical stapling device includes an elongate body and a tool assembly supported on a distal portion of the elongate body. The tool assembly includes a cartridge assembly and an anvil assembly that are movable in relation to each other between spaced and approximated positions. The cartridge assembly includes a staple cartridge supporting a plurality of staples, a clamp member having a body supporting a knife, and an actuation sled having a first portion and a second portion. Each of the first and second portions of the actuation sled defines a cam member. The second portion of the actuation sled is physically separated and spaced from the first portion of the actuation sled to define a channel between the first and second portions. In a pre-actuated state of the surgical stapling device, the clamp member is positioned within the channel defined between the first and second portions of the actuation sled such that the knife of the clamp member is positioned distally of a proximal end of the cam member of the first and second portions of the actuation sled. During at least a portion of a firing stroke of the surgical stapling device, the clamp member is movable to position the knife proximally of the cam members.

In embodiments, the cam member of each of the first and second portions of the actuation sled includes first and second cam members.

In some embodiments, the clamp member includes a vertical strut, an upper beam, and a lower beam, and in the pre-actuated state, the vertical strut is positioned within a proximal portion of the channel.

In certain embodiments, each of the first and second portions of the actuation sled includes an inner wall having a longitudinally extending portion and a transverse portion.

In embodiments, the longitudinally extending portion of the inner wall of each of the first and second portions of the actuation sled includes an inwardly extending resilient projection that extends into the channel into the path of the clamp member, wherein in the pre-actuated state, the clamp member is positioned to engage the resilient projections to urge the resilient projections from within the channel.

In some embodiments, the firing stroke includes a first advancement stage in which a distal surface of the clamp member is positioned to engage the transverse portion of the inner wall of the first and second portions of the actuation sled to move the actuation sled distally within the tool assembly.

In certain embodiments, the firing stroke includes a retraction stage in which the clamp member moves proximally within the channel to position the distal surface of the clamp member proximally of the resilient projections of the first and second portions of the actuation sled such that the resilient projections move into the channel.

In embodiments, the cartridge assembly includes a support plate having a resilient protrusion, wherein the actuation sled is positioned atop the resilient protrusion when the clamp member is in the pre-actuated state to urge the resilient protrusion from within the channel, and the actuation sled is positioned distally of the resilient protrusion when the stapling device is moved through the first advancement stage of the firing stroke such that the resilient protrusion prevents proximal movement of the actuation sled within the tool assembly during the retraction stage of the firing stroke.

In some embodiments, the clamp member has a base having opposed laterally extending flats that are positioned to engage the resilient projections in the pre-actuated state.

In certain embodiments, the base of the clamp member includes proximal stop members positioned at a proximal portion of the laterally extending flats.

In embodiments, the clamp member defines a threaded bore and the surgical stapling device further includes a threaded drive member, the threaded drive member being received within the threaded bore such that rotation of the threaded drive member causes axial movement of the clamp member.

In another aspect of the disclosure, a surgical stapling device includes an elongate body and a tool assembly supported on a distal portion of the elongate body. The tool assembly includes a cartridge assembly and an anvil assembly that are movable in relation to each other between spaced and approximated positions. The cartridge assembly includes a staple cartridge supporting a plurality of staples, a clamp member having a body supporting a knife, and an actuation sled having first and second spaced cam members. The first and second spaced cam members defining a channel there between. Each of the first and second cam members includes an inner cam member and an outer cam member. The inner cam members include a flexible portion supporting an inwardly extending protrusion, the flexible portion being flexible laterally to allow the clamp member to move proximally from within the channel to a position proximal of the channel.

In embodiments, the inwardly extending protrusions extend into the channel to obstruct movement of the clamp member within the channel.

In some embodiments, the inwardly extending protrusions have tapered distally facing surfaces.

In certain embodiments, in a pre-actuated state of the surgical stapling device, the clamp member is positioned within the channel of the actuation sled with the knife of the clamp member positioned distally of a proximal end of the first and second cam members of the actuation sled, wherein during at least a portion of a firing stroke of the surgical stapling device, the clamp member is movable to position the knife proximally of the first and second cam members.

In embodiments, the staple cartridge defines a longitudinal axis, a central knife slot extending along the longitudinal axis, and outer and inner cam slots positioned on each side of the central knife slot, wherein the outer and inner cam members are received in the outer and inner cam slots, respectively.

In some embodiments, in a pre-actuated state of the surgical device, the inner and outer cam members of the actuation sled extend beyond the proximal end of the inner and outer cam slots when the actuation sled is in the pre-actuated position such that the inner and outer cam members are angled outwardly in a direction away from the central knife slot to a position misaligned with the longitudinal axis of the staple cartridge.

In certain embodiments, the actuation sled includes a cross-member interconnecting a distal end of the inner cam members to each other.

In embodiments, the surgical stapling device is movable through a firing stroke, the firing stroke including a first advancement stage wherein a distal surface of the clamp member is positioned to engage the cross-member of the actuation sled to advance the actuation sled distally within the tool assembly.

In some embodiments, the firing stroke includes a retraction stage in which the clamp member moves proximally from within the channel into engagement with the inwardly extending protrusions on the flexible portions of the inner cam members to move the flexible portions to the misaligned position and allow the clamp member to move out of the channel of the actuation sled.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed surgical stapling device including a tool assembly with minimal dead space are described herein below with reference to the drawings, wherein:

FIG. 1 is a side, perspective view of a surgical stapling device including one embodiment of the presently disclosed tool assembly in an open position;

FIG. 2 is a side, perspective of the tool assembly shown in FIG. 1 in approximated position;

FIG. 3 is a side, perspective, exploded view of the tool assembly shown in FIG. 2;

FIG. 4 is an enlarged view of the indicated area of detail shown in FIG. 3;

FIG. 5 is an enlarged view of the indicated area of detail shown in FIG. 3;

FIG. 6 is a perspective view from the distal end of an actuation sled of the tool assembly shown in FIG. 5;

FIG. 7 is a side, perspective view from the distal end of the actuation sled and clamping member of the tool assembly shown in FIG. 5;

FIG. 8 is a side, perspective view of the clamp member and actuation sled shown in FIG. 7 supported on a drive screw of the tool assembly shown in FIG. 3;

FIG. 9 is a cross-sectional view taken along section line 9-9 of FIG. 8;

FIG. 10 is a cross-sectional view taken along section line 10-10 of FIG. 1;

FIG. 11 is a perspective, cutaway view of the cartridge assembly of the tool assembly shown in FIG. 3 with the cartridge channel removed;

FIG. 11A is a cross-sectional view taken along section line 11A-11A of FIG. 11;

FIG. 12 is a side cross-sectional view of the cartridge assembly of the tool assembly shown in FIG. 2 in the approximated position;

FIG. 13 is a bottom perspective view of the cartridge assembly of the tool assembly shown in FIG. 3 with the cartridge channel removed and the tool assembly in the approximated position of the tool assembly;

FIG. 14 is a cross-sectional view taken along section line 14-14 of FIG. 12;

FIG. 15 is a side cross-sectional view of the tool assembly shown in FIG. 12 as the tool assembly is moved through a first stage of a firing stroke;

FIG. 16 is a side cross-sectional view of the tool assembly shown in FIG. 15 as the tool assembly is moved through a second stage of the firing stroke;

FIG. 17 is a top, perspective view of the tool assembly shown in FIG. 16 showing the actuation sled and clamping member of the tool assembly with the remaining components of the tool assembly shown in phantom;

FIG. 18 is a side cross-sectional view of the tool assembly shown in FIG. 16 as the tool assembly is moved through a third stage of the firing stroke;

FIG. 19 is a side perspective view from the proximal end of another embodiment of an actuation sled and clamping member of the presently disclosed surgical stapling device shown in FIG. 1 with parts separated;

FIG. 20 is a side perspective view from the distal end of the actuation sled and clamping member shown in FIG. 19 with parts separated;

FIG. 21A is a side, cross-sectional view of a proximal portion of the tool assembly shown in FIG. 1 including the actuation sled and clamping member shown in FIG. 19 with the tool assembly in an unclamped position;

FIG. 21B is a top, schematic view of a cartridge assembly of the tool assembly shown in FIG. 21A;

FIG. 21C is a cross-sectional view taken along section line 21C-21C of FIG. 21B;

FIG. 21D is a side, perspective view from the proximal end of the actuation sled and clamping member shown in FIG. 19 assembled in the unclamped position;

FIG. 22A is a side cross-sectional view of the tool assembly of the surgical stapling device shown in FIG. 1 with the actuation sled and clamping member shown in FIG. 19 in the clamped position;

FIG. 22B is a top, schematic view of the tool assembly shown in FIG. 22A;

FIG. 22C is a side, perspective view from the distal end of the actuation sled and clamping member shown in FIG. 19 assembled in the clamped position;

FIG. 23 is a top, schematic view of the tool assembly shown in FIG. 22B as the tool assembly is moved through a first stage of a firing stroke;

FIG. 24 is a top, schematic view of the tool assembly shown in FIG. 22B as the tool assembly is moved through a second stage of the firing stroke;

FIG. 25A is a top, schematic view of the tool assembly shown in FIG. 24 after the tool assembly is moved through the second stage of the firing stroke;

FIG. 25B is a side, perspective view of the actuation sled and clamping member of the tool assembly shown in FIG. 25A; and

FIG. 26 is a top, schematic view of the tool assembly shown in FIG. 25A as the tool assembly is moved through a third stage of the firing stroke.

DETAILED DESCRIPTION OF EMBODIMENTS

The presently disclosed surgical stapling device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term “endoscopic” is used generally used to refer to endoscopic, laparoscopic, arthroscopic, and/or any other procedure conducted through small diameter incision or cannula. Further, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel.

The presently disclosed surgical stapling device includes a handle assembly, an elongate body extending distally from the handle assembly, and a tool assembly which is supported on a distal portion of the elongate body. In embodiments, the tool assembly is mounted onto the distal portion of the elongate body for articulation and includes a staple cartridge that supports a plurality of staples and pushers, an actuation sled that is movable through the staple cartridge to eject staples from the staple cartridge, and a drive or clamp member. The clamp member is movable through the tool assembly to move the tool assembly from an open position to an approximated position and to advance the actuation sled through the staple cartridge to eject the plurality of staples from the staple cartridge and to cut tissue. In order to minimize the length of the dead space in the proximal portion of the tool assembly, the actuation sled and clamp member are supported in a nested relationship within the staple cartridge when the tool assembly is in an unclamped or open position.

FIG. 1 illustrates a surgical stapling device 10 including a handle assembly 12, an elongate body 14, and an exemplary embodiment of the presently disclosed tool assembly 100. Although not described in detail herein, the tool assembly 100 can form part of a reload assembly 16 that includes a shaft portion 16 a that supports the tool assembly 100 and is releasable from elongate body 14 as is known in the art. Alternately, the tool assembly 100 can be fixedly secured to a distal portion of the elongate body 14. The tool assembly 100 may or may not have a removable and replaceable staple cartridge assembly.

The handle assembly 12 includes a hand grip 18, a plurality of actuator buttons 20, and a rotation knob 22. The rotation knob 22 facilitates rotation of the elongate body 14 and the reload 100 about a longitudinal axis of the elongate body 14 in relation to the handle assembly 12 as is known in the art. The actuator buttons 20 control operation of the various functions of the stapling device 10 including approximation, firing and cutting. The stapling device 10 is illustrated as being an electrically powered stapling device such as described in U.S. Pat. No. 9,055,943 (“'943 patent”) which is incorporated herein by reference in its entirety. However, it is envisioned that the presently disclosed tool assembly 100 would also be suitable for use with manually powered surgical stapling devices such as described in U.S. Pat. No. 7,891,534 which is also incorporated herein by reference in its entirety. It is also envisioned that the stapling device 10 can be configured for use with a robotic surgical system and may not have a handle assembly.

Referring to FIGS. 2-4, the tool assembly 100 includes an anvil 102 and a cartridge assembly 104. The cartridge assembly 104 includes a staple cartridge 106 that supports a plurality of staples 108 and pushers 110 (FIG. 3), a cartridge channel 112 defining a bottom surface 112 a, a staple cartridge support plate 114, a drive screw 116, a clamp member 118, and an actuation sled 120. The support plate 114 includes a resilient protrusion, e.g., a resilient lance 114 a (FIG. 4), that defines a stop surface for the actuation sled 120 as described in further detail below. Alternatively other protrusion configurations are envisioned. The staple cartridge 106 defines a central knife slot 140 (FIG. 3) and is attached within the support plate 114 by a snap-fit connection. The support plate 114 and staple cartridge 106 are assembled together and attached to the cartridge channel 112 also by a snap-fit connection. Alternately, other techniques for securing these components together may be used.

Referring to FIG. 3, the staple cartridge 106 includes a tissue contact surface 124 that defines a plurality of rows of laterally spaced staple retention slots 124 a. The retention slots 124 a are configured as holes in the tissue contacting surface 124. Each retention slot 124 a receives one of the staples 108 and at least a portion of a respective one of the pushers 110. The staple cartridge 106 also defines a plurality of longitudinal cam slots 106 a (FIG. 11A). The longitudinal cam slots 106 a accommodate the staple pushers 110 (FIG. 11) and are open on an end opposite to the tissue-contacting surface 124 to facilitate passage of the actuation sled 120.

The anvil 102 is pivotally coupled to the cartridge assembly 104 about pivot members 122. The pivot members 122 extend through openings 125 (FIG. 3) defined in a proximal portion of the anvil 102 and openings 127 defined in a proximal portion of the cartridge assembly 106. The anvil 102 is pivotal in relation to the cartridge assembly 106 to transition the tool assembly 100 between an open position (FIG. 1) and an approximated position (FIG. 2). The anvil 102 includes a tissue contact surface 102 a (FIG. 10) that defines a plurality of staple deforming depressions (not shown) as is known in the art. The anvil 102 also defines a channel 129 (FIG. 10) and includes a ramped abutment surface 128 (FIG. 10) and a tissue stop 130. The ramped abutment surface 128 is positioned adjacent a proximal end of the channel 129 and is engaged by the clamp member 118 to facilitate movement of the tool assembly 100 from the open position to the approximated position. In embodiments, the tissue stop 130 includes a pair of downwardly extending wings 130 a positioned on opposite sides of the tissue contact surface 102 a of the anvil 102. Each of the wings 130 a has a distal tissue engaging surface 130 b that extends below the tissue contact surface 124 of the staple cartridge 106 when the tool assembly 100 is in the open position. The distal engaging surface 130 b of the tissue stop 130 prevents tissue from passing between the anvil and cartridge assemblies 102, 104 of the tool assembly 100 proximally beyond the staple retention slots 124 a.

Referring also to FIGS. 5-9, the clamp member 118 includes a base 142 having a distal surface 142 a, a vertical strut 144, an upper beam 146, and a lower beam 148. The vertical strut 144 has a first end secured to the base 142 and a second end secured to the upper beam 146. In some embodiments, the base 142 is substantially cylindrical and defines a threaded bore 150 that rotatably receives the drive screw 116 (FIG. 3). In embodiments, the base 142 includes opposed longitudinally extending flats 164 and proximal stop members 166 that are discussed in further detail below. In some embodiments, the drive screw 116 (FIG. 9) is threaded and is received within the threaded bore 150 of the clamp member 118 to translate rotational movement of the drive screw 116 into longitudinal movement of the clamp member 118.

The vertical strut 144 includes a distal surface that defines a knife 152 that is positioned between the upper and lower beams 146, 148. The upper beam 146 is positioned to engage the ramped abutment surface 128 (FIG. 10) of the anvil assembly 102 such that movement of the clamp member 118 from a retracted position to a clamped position transitions the tool assembly 100 from the open position (FIG. 10) to the approximated position (FIG. 12). The upper beam 146 is also positioned to translate through the channel 129 (FIG. 10) defined in the anvil assembly 102 and the lower beam 148 is positioned to translate along the bottom surface 112 a (FIG. 10) of the cartridge channel 112 to prevent outward deflection of the anvil 102 and the cartridge assembly 104 during firing of the stapling device 10. The upper and lower beams 146, 148 are dimensioned to allow for a maximum tissue gap “X” (FIG. 12) between the tissue contact surface 102 a of the anvil assembly 102 and the tissue contact surface 124 of the staple cartridge 106 during firing of the tool assembly 100.

The actuation sled 120 includes a first portion 120 a including a first pair of spaced cam members 170 a and a second portion 120 b including a second pair of spaced cam members 170 b. The first and second portions 120 a and 120 b of the actuation sled 120 may be separate components as shown. Alternately, the first and second portions of the actuation sled 120 can be joined at their proximal and/or distal ends to each other. Each pair of spaced cam members 170 a, 170 b is positioned to translate through a respective longitudinal cam slot 106 a (FIG. 11A) defined by the staple cartridge 106 to interact with the pushers 110 (FIG. 3) and eject staples 108 from the staple cartridge 106 as is known in the art. In embodiments, each of the pair of spaced cam members 170 a, 170 b includes two spaced cam surfaces 174, 176 that sequentially engage the pushers 110 (FIG. 3) as the actuation sled 120 translates through the staple cartridge 106 to lift the pushers 110 within the staple retention slots 124 a of the staple cartridge 106 and eject the staples 108 from the staple retention slots 124 a of the staple cartridge 106. The angle of the cam surfaces 174, 176 may vary along the length of the cam surfaces 174, 176 to better control movement of the pushers 108 through the staple retention slots 124 a and provide better staple formation. For example, the cam surfaces 174, 176 may have a distal portion 180 and a proximal portion 182 wherein the proximal portion 182 is steeper than the distal portion 180.

Referring also to FIGS. 5-11A, each of the first and second portions 120 a, 120 b of the actuation sled 120 includes an inner wall 184 with a longitudinally extending portion 184 a having an inwardly extending resilient projection 185 (FIG. 6), and a transverse portion 184 b. When the first and second portions 120 a, 120 b of the actuation sled 120 are positioned within the staple cartridge 106, the first and second portions 120 a and 120 b define a channel 188 that is positioned to receive the base 142 of the clamp member 118 such that the clamp member 118 is movable within the channel 188 from a retracted position to an advanced position. In an unbiased state, the resilient projections 185 extend inwardly into the channel 188. The transverse portions 184 b of the first and second portions 120 a, 120 b of the actuation sled 120 define a distal end of the channel 188 and are positioned to engage the distal surface 142 a (FIG. 5) of the clamp member 118 when the clamp member 118 is moved to the advanced position within the channel 188. The actuation sled 118 and the clamp member 120 form an assembly in which the first and second portions 120 a, 120 b of the actuation sled 120 are disposed alongside the clamp member 120 including the knife 152.

When the base 142 of the clamp member 118 is positioned between the first and second portions 120 a, 120 b of the actuation sled 120 (FIG. 8), the flats 164 (FIG. 5) of the base 142 are aligned with the resilient projections 185 of the actuation sled 120 to bias and retain the resilient projections 185 in alignment with a respective one of the inner walls 184 of the first and second portions 120 a, 120 b of the actuation sled 120. When the resilient portions 185 are biased inwardly from the channel 188, the clamp member 118 is free to move through the channel 188 and into engagement with the transverse portions 184 b of the inner wall 184 of the first and second portions 120 a, 120 b of the actuation sled 120. When the clamp member 118 is moved within the channel 188 in relation to the actuation sled 120 such that the flats 164 are positioned proximally of the resilient projections 184 a as discussed below, the resilient projections 185 spring into the channel 188 defined between the first and second portions 120 a, 120 b of the actuation sled 120 to a position aligned with the distal surface 142 a (FIG. 5) of the clamp member 118. As such, distal movement of the clamp member 118 beyond the resilient projections 185 is prevented.

Referring to FIGS. 8-11A, when the surgical stapling device 10 is in a pre-actuated state, the clamp member 118 and the actuation sled 120 are in a nested configuration. In the nested configuration, the clamp member 118 is positioned between the first and second portions 120 a and 120 b of the actuation sled 120 within the channel 188 (FIG. 6) such that the distal surface 142 a of the base member 142 of the clamp member 118 is positioned proximally a distance “Y” (FIG. 9) from the transverse portions 184 b of the inner walls 184 of the first and second portions 120 a, 120 b of the actuation sled 120. In this position, the flats 164 (FIG. 5) of the base member 142 (FIG. 6A) are aligned with the resilient projections 185 of the inner wall 184 of the actuation sled 120 such that the projections 185 are urged out of the channel 188 of the actuation sled 120. In addition, the actuation sled 120 is positioned atop the lance 114 a (FIG. 10) of the support plate 114 of the cartridge assembly 104 to urge the lance 114 a out of the channel 188 defined between the first and second portions 120 a, 120 b of the actuation sled 120.

The drive screw 116 extends through the threaded bore 150 of the clamp member 118 and includes a proximal portion “P” (FIG. 10) supported on a bearing and that is coupled to a drive member (not shown) supported within the elongate body 114 (FIG. 1) of the surgical stapling device 10. U.S. Pat. No. 8,512,359 discloses a surgical stapling device including a drive screw and drive member and is incorporated herein in its entirety by reference.

Referring to FIGS. 12-14, when the drive screw 116 is actuated via the handle assembly 12 (FIG. 1) and the elongate body 14 (FIG. 1) to advance the clamp member 118 through a clamping stroke of the surgical stapling device 10, the clamp member 118 moves from a retracted position to a clamped position. As the clamp member 118 moves towards the clamped position, the clamp member 118 moves along the drive screw 116 distally through the channel 188 defined between the first and second portions 120 a, 120 b of the actuation sled 120 independently of the actuation sled 120. As the clamp member 118 moves distally within the proximal portion of the tool assembly 100, the upper beam 146 of the clamp member 118 engages the ramped abutment surface 128 (FIG. 12) of the anvil assembly 102 such that continued distal movement of the clamp member 118 in the direction indicated by arrow “A” in FIG. 12 to the clamped position pivots the anvil assembly 102 in the direction indicated by arrow “B” in FIG. 12 to urge the tool assembly 100 from the open position (FIG. 10) to the approximated position. It is envisioned that the anvil assembly 102 may be stationary and the cartridge assembly 104 may pivot in relation to the anvil assembly 102 from the open position to the approximated position.

When the clamp member 118 is in the clamped position, the distal surface 142 a (FIG. 12) of the base 142 of the clamp member 118 is positioned adjacent the transverse portions 184 b of the inner walls 184 of the first and second portions 120 a, 120 b of the actuation sled 120. In this position, the flats 164 of the base member 142 (FIG. 11A) are still aligned with the resilient projections 185 of the inner wall 184 of the actuation sled 120 such that the resilient projections 184 a are positioned outwardly of the channel 188 of the actuation sled 120. In addition, the tool assembly 100 is in the approximated position with the tissue contact surface 124 of the cartridge assembly 106 positioned in juxtaposed alignment with the tissue contact surface 102 a of the anvil assembly 102 to define a maximum tissue gap “X” (FIG. 12). The actuation sled 120, which has not moved within the tool assembly 100, remains positioned atop the lance 114 a of the support plate 114 of the cartridge assembly 104.

In order to eject staples 108 (FIG. 3) from the tool assembly 100, the drive member 116 is actuated again via the handle assembly 12 and the elongate body 14 (FIG. 1) to move the clamp member 118 through a firing stroke. During the firing stroke, the clamp member 118 and the actuation sled 120 are moved through a first advancement stage shown in FIG. 15, through a retraction stage shown in FIGS. 16 and 17, and through a second advancement stage shown in FIG. 18. Each of these stages is described below.

Referring to FIG. 15, during the first advancement stage of the firing stroke, the drive screw 116 initially advances the clamp member 118 in the direction indicated by arrows “C” distally from the clamped position. As discussed above, in the clamped position the distal surface 142 a of the base 142 of the clamp member 118 is positioned adjacent the transverse portions 184 b of the inner walls 184 of the first and second portions 120 a, 120 b of the actuation sled 120. As such, when the clamp member 118 moves distally within the tool assembly 100 from the clamped position, the distal surface 142 a of the clamp member 118 engages the transverse portions 184 b of the actuation sled 120 to advance the actuation sled 120 distally within the cartridge 106. When the actuation sled 120 is advanced past the lance 114 a, the lance 114 a flexes upwardly into the path of the actuation sled 120 and the first advancement stage of the firing stroke ends.

Referring to FIGS. 16 and 17, during the retraction stage of the firing stroke, the drive screw 116 is rotated in an opposite direction to that of the rotational direction of the drive screw 116 in the first stage of the firing stroke to retract the clamp member 118 within the tool assembly 100 in the direction indicated by arrows “D”. The lance 114 a which is positioned within the channel 118 of the actuation sled 120 engages a proximal end of the actuation sled 120 to prevent proximal movement of the actuation sled 120 with the clamp member 118. As such, the clamp member 118 moves proximally independently of the actuation sled 118 within the tool assembly 100. As the clamp member 118 moves proximally, the distal surface 142 a of the clamp member 118 passes over the resilient projections 185 of the actuation sled 120 such that the resilient projections 185 spring outwardly into the channel 188 of the actuation sled 120 to prevent distal movement of the clamp member 118 through the channel 188 beyond the resilient projections 184. By moving and retaining the clamp member 118 further proximally of the actuation sled 120, the tool assembly 100 is reconfigured to position the cam surfaces 174, 176 of the actuation sled 120 distally of the knife 152 such that the tool assembly 100 staples tissue prior to cutting tissue.

Referring to FIG. 18, after the retraction stage of the firing stroke, the distal surface 142 a of the base 142 of the clamp member 118 is positioned proximally of the resilient projections 185 of the actuation sled 120. During the second advancement stage of the firing stroke, the drive screw 116 is rotated to advance the clamp member 118 distally in the direction indicated by arrow “E” through the tool assembly 100. Since the distal surface 142 a of the base 142 of the clamp member 118 is positioned slightly proximally of the resilient projections 185 of the actuation sled 120, distal movement of the clamp member 118 causes the distal surface 142 a of the clamp member 118 to move into engagement with the resilient projections 185 to move the actuation sled 120 distally within the tool assembly 100. As the actuation sled 120 and the clamp member 118 are advanced through the tool assembly 100, the pair of spaced cam members 170 a, 170 b of the first and second portions 120 a, 120 b of the actuation sled 120 sequentially engage the pushers 110 (FIG. 3) to sequentially drive the staples 108 from the staple retention slots 124 a (FIG. 17).

After the second advancement stage of the firing stroke, the tool assembly can be withdrawn from the surgical site and the drive screw 116 can be rotated to retract the clamp member 118 to it pre-fired state. When the clamp member 118 returns to the pre-fired state, the tool assembly is returned to the open position.

FIGS. 19 and 20 illustrate an alternate embodiment of the presently disclosed clamp member 218 and actuation sled 220 which can be used with the surgical stapling device shown in FIG. 1. The clamp member 218 includes a base 242, a vertical strut 244, an upper beam 246, and a lower beam 248. The vertical strut 244 has a first end secured to the base 242 and a second end secured to the upper beam 246. In embodiments, the base 242 defines a threaded bore 250 that rotatably receives a drive screw 116 (FIG. 3). As discussed above in regard to tool assembly 100, the drive screw 116 is threaded and is rotatable within the threaded bore 250 of the clamp member 218 to translate the rotational movement of the drive screw 116 into longitudinal movement of the clamp member 218 within a tool assembly 200 (FIG. 21A).

Referring also to FIG. 21A, the vertical strut 244 of the clamp member 218 includes a distal surface that defines a knife 252 that is positioned between the upper and lower beams 246, 248. The upper beam 246 is positioned to engage an abutment surface 228 of an anvil assembly 202 of the tool assembly 200 such that movement of the clamp member 218 from a retracted position (FIG. 21A) to a clamped position (FIG. 22A) moves the tool assembly 200 from the open position to the approximated position. As discussed above in regard to the tool assembly 100, the upper beam 246 of the clamp member 218 is positioned to translate through a channel 229 (FIG. 21A) defined in the anvil assembly 202 and the lower beam 248 is positioned to translate along the bottom surface 212 a (FIG. 21A) of a cartridge channel 212 of a cartridge assembly 204 to define a maximum tissue gap “X” (FIG. 22A) between a tissue contact surface 202 a of the anvil assembly 202 and a tissue contact surface 224 of the staple cartridge 206 of the tool assembly 200 when the tool assembly 200 is in the approximated position. The base 242 of the clamp member 218 also includes a distal surface 242 a (FIG. 19) that is positioned to engage and advance the actuation sled 220 as described in further detail below.

The actuation sled 220 includes cam members 270 a, 270 b (FIG. 20) that are substantially similar to the spaced cam members 170 a, 170 b described above in regard to the actuation sled 120 and will not be described in further detail herein. The cam members 270 a, 270 b are spaced and define a channel 271 having an open proximal end and a distal end that is enclosed by a cross member 288. Each of the cam members 270 a, 270 b includes a first outer cam member 274 and a second inner cam member 276 which have cam surfaces as described above in regard to cam surfaces 174 and 176 and will not be described in further detail herein. The outer and inner cam members 274, 276 are laterally flexible and resilient. The inner cam member 276 includes a flexible portion 277 (FIG. 20) having an inwardly extending protrusion 277 a that has a tapered distal surface.

Referring also to FIG. 21A-21C, the staple cartridge 206 defines a longitudinal axis, a central knife slot 240 extending along the longitudinal axis, and an outer and an inner cam slot 206 a, 206 b positioned on each side of the central knife slot 240. The outer cam slots 206 a receive the outer cam members 274 of the actuation sled 220 and the inner cam slots 206 b receive the inner cam members 276 of the actuation sled 220. The outer and inner cam members 274 and 276, respectively of the actuation sled 220 are laterally resilient and have proximal ends that, in an unbiased state, are angled outwardly in a direction away from the central knife slot 240 to a position misaligned with the longitudinal axis of the staple cartridge (“the misaligned position”). The outer and inner cam slots 206 a, 206 b define a proximal end 206 c (FIG. 21 B) that is positioned distally of the proximal end of the staple cartridge 206. When the actuation sled 220 is in a fully retracted position, as described in further detail below, the inner and outer cam members 276 and 274 are positioned proximally beyond the proximal end 206 c of the inner and outer cam slots 206 b, 206 a, such that the inner and outer cam members 276 and 274 are in the misaligned position (FIG. 21B). When the actuation sled 220 is advanced within the staple cartridge 206 from the fully retracted position, the inner and outer cam members 276, 274 move into the inner and outer cam slots 206 b, 206 a and are biased inwardly by walls defining the cam slots 206 a, 206 b to an aligned position in which the cam members 276, 274 are aligned with the longitudinal axis of the staple cartridge 206 (FIG. 23).

In the misaligned position of the inner and outer cam members 276, 274, the protrusions 277 a on the flexible portion 277 of the actuation sled 220 are spaced from each other a distance to allow the base 242 of the clamp member 218 to pass between the protrusions 277 a of the flexible portion 277 of the actuation sled 220 into the channel 271. In the aligned position of the inner and outer cam members 274, the protrusions 277 a on the flexible portion 277 of the actuation sled 220 are spaced from each other a distance to prevent passage of the clamp member 218 proximally through the channel 271.

Referring briefly to FIG. 21A, the tool assembly 200 includes a support plate 214 that is similar to support plate 114 (FIG. 3) and includes a resilient protrusion, e.g., a resilient lance 214 a (see also FIG. 4), that defines a stop surface for the actuation sled 220. When the actuation sled 218 is in its retracted position, the sled 218 is positioned atop the lance 214 a to urge the lance 214 a out of the path of the actuation sled 220. When the proximal end of the actuation sled 220 moves distally past the lance 214 a, the lance 214 a springs upwardly to a position to prevent proximal movement of the actuation sled 220 back to its retracted position.

Referring to FIGS. 21A-D, prior to actuating the tool assembly 200, the clamp member 218 and the actuation sled 220 are in a pre-clamped position. In the pre-clamped position, the clamp member 218 and the actuation sled 220 are in a nested relationship (FIG. 21D) in their retracted positions with the clamp member 218 located in a proximal portion of the channel 271 of the actuation sled 220 between the protrusions 277 a on the flexible portions 277 of the actuation sled 220. In this position, the actuation sled 220 is positioned atop the lance 214 a to bias the lance 214 a out of the channel 271 of the actuation sled 220. In the pre-clamped position, substantially all of the length of the inner and outer cam members 276, 274 is positioned proximally of the proximal end 206 c (FIG. 21B) of the inner and outer cam slots 206 b, 206 a.

Referring to FIGS. 22A-22C, when the drive screw 116 (FIG. 3) is actuated via the handle assembly 12 (FIG. 1) to advance the clamp member 218 through a clamping stroke, the clamp member 218 moves distally within the tool assembly 200 (FIG. 22A) independently of the actuation sled 220 in the direction indicated by arrow “F” in FIG. 22A from its retracted position (FIG. 21B) to the clamped position (FIG. 22B). As the clamp member 218 moves towards the clamped position through the channel 271 of the actuation sled 220, the upper beam 246 of the clamp member 218 engages the abutment surface 228 (FIG. 22A) of the anvil assembly 202 to pivot the anvil assembly 202 in the direction indicated by arrow “G” in FIG. 22A to the approximated position. Since the actuation sled 220 remains in an axially fixed position within the tool assembly, the actuation sled 220 remains positioned atop the lance 214 a and the inner and outer cam members 276, 274 remain in the misaligned position located proximally of the proximal end 206 c of the inner and outer cam slots 206 b, 206 a. In the clamped position of the clamp member 218, the clamp member 218 is positioned adjacent the cross-member 288 of the actuation sled 220.

In order to eject staples from the tool assembly 200, the drive member 116 (FIG. 3) is actuated again via the handle assembly 12 (FIG. 1) to move the clamp member 218 through a firing stroke. During the firing stroke, the clamp member 218 and the actuation sled 220 are moved through a first advancement stage shown in FIG. 23, through a retraction stage shown in FIGS. 24-25B, and through a second advancement stage shown in FIG. 26. Each of these stages is described below.

Referring to FIG. 23, during the first advancement stage of the firing stroke, the drive screw 116 (FIG. 3) advances the clamp member 218 in the direction indicated by arrows H. As the clamp member 218 moves distally through the tool assembly 200, the inner and outer cam members 276, 274 are advanced partially into the inner and outer cam slots 206 b, 206 a, respectively, such that the inner and outer cam members 276, 274 move to a position aligned with the longitudinal axis of the staple cartridge 206. After the first advancement stage of the firing stroke, the flexible portion 277 of the inner cam members 276 remains positioned proximally of the proximal end 206 c of the outer cam slots 206 a.

As the clamp member 218 moves distally within the tool assembly 200 during the first advancement stage of the firing stroke, the distal surface 242 a of the clamp member 218 engages the cross member 288 of the actuation sled 220 to cause corresponding distal movement of the actuation sled 220 in the direction indicated by arrow “I”. As the actuation sled 220 moves distally within the tool assembly 220, the actuation sled 220 moves off of the lance 214 a (FIG. 22A) such that the lance 214 a springs upwardly to a position proximally of the proximal end of the actuation sled 220.

Referring to FIG. 24-25B, during the retraction stage of the firing stroke, the drive screw 116 (FIG. 3) is rotated in an opposite direction to retract the clamp member 218 in the direction indicated by arrow “J” in FIG. 24 within the tool assembly 100. The lance 214 a prevents proximal movement of the actuation sled 220 such that the clamp member 118 moves proximally within the channel 271 of the actuation sled 220 independently of the actuation sled 218. As the clamp member 218 moves proximally within the tool assembly 200, a proximal end of the base member 242 of the clamp member 218 engages a tapered distal surface of the inwardly extending protrusion 277 a on the flexible portion 277 of the inner cam member 276 of the actuation sled 220. As discussed above, after the first advancement stage of the firing stroke, the flexible portion 277 of the inner cam member 276 is positioned proximally of the inner cam slot 206 b. As such, when the base member 242 of the clamp member 218 engages the distal tapered surfaces of the protrusions 277 a of the flexible portion 277, the flexible portion 277 of the inner cam member 276 flexes outwardly in the direction indicated by arrow “K” in FIG. 24 to allow the clamp member 218 to move proximally from within the channel 271 of the actuation sled 220 to a position proximally of the actuation sled 220 (FIGS. 25A-B). This movement allows the clamp member 218 to move proximally of the actuation sled 220 to position the knife 252 proximally of the inner and outer cam members 276, 274 such that during firing of the stapling device 10, stapling occurs before cutting of tissue.

Referring to FIG. 26, during the second advancement stage of the firing stroke, the drive screw 116 (FIG. 3) is rotated to advance the clamp member 218 distally in the direction indicated by arrow “L” through the tool assembly 200 (FIG. 22A). Since the distal surface 242 a of the clamp member 218 is positioned adjacent to the proximal side of the actuation sled 220 proximally of the protrusions 277 a, distal movement of the clamp member 218 effects distal movement of the actuation sled 220 within the tool assembly 200. As the actuation sled 220 and the clamp member 218 are advanced through the tool assembly 200, the inner and outer cam members 276, 274 of the actuation sled 220 sequentially engage the pushers 110 (FIG. 3) to sequentially drive the staples 108 from the staple retention slots 124 a and into tissue clamped between the cartridge and anvil assemblies.

Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. 

What is claimed is:
 1. A surgical stapling device comprising: an elongate body; and a tool assembly supported on a distal portion of the elongate body, the tool assembly including a cartridge assembly and an anvil assembly that are movable in relation to each other between spaced and approximated positions, the cartridge assembly including a staple cartridge supporting a plurality of staples, a clamp member having a body supporting a knife, and an actuation sled having a first portion and a second portion, each of the first and second portions of the actuation sled defining a cam member, the second portion of the actuation sled being physically separated and spaced from the first portion of the actuation sled to define a channel between the first and second portions, wherein in a pre-actuated state of the surgical stapling device, the clamp member is positioned within the channel between the first and second portions of the actuation sled with the knife of the clamp member positioned distally of a proximal end of the cam member of the first and second portions of the actuation sled, wherein during at least a portion of a firing stroke of the surgical stapling device, the clamp member is movable to position the knife proximally of the cam members.
 2. The surgical stapling device of claim 1, wherein the cam member of each of the first and second portions of the actuation sled includes first and second cam members.
 3. The surgical stapling device of claim 2, wherein the clamp member includes a vertical strut, an upper beam, and a lower beam, and in the pre-actuated state, the vertical strut is positioned within a proximal portion of the channel.
 4. The surgical stapling device of claim 3, wherein each of the first and second portions of the actuation sled include an inner wall including a longitudinally extending portion and a transverse portion.
 5. The surgical stapling device of claim 4, wherein the longitudinally extending portion of the inner wall of the first and second portions of the actuation sled includes an inwardly extending resilient projection that extends into the channel into the path of the clamp member, wherein in the pre-actuated state, the clamp member is positioned to engage the resilient projections to urge the resilient projections from within the channel.
 6. The surgical stapling device of claim 5, wherein the firing stroke includes a first advancement stage wherein a distal surface of the clamp member is positioned to engage the transverse portion of the inner wall of the first and second portions of the actuation sled to move the actuation sled distally within the tool assembly.
 7. The surgical stapling device of claim 6, wherein the firing stroke includes a retraction stage in which the clamp member moves proximally within the channel to position the distal surface of the clamp member proximally of the resilient projections of the first and second portions of the actuation sled such that the resilient projections move into the channel.
 8. The surgical stapling device of claim 7, wherein cartridge assembly includes a support plate having a resilient protrusion, wherein the actuation sled is positioned atop the resilient protrusion when the clamp member is in the pre-actuated state to urge the resilient protrusion from within the channel, and the actuation sled is positioned distally of the resilient protrusion when the stapling device is moved through the first advancement stage of the firing stroke such that the resilient protrusion prevents proximal movement of the actuation sled during the retraction stage of the stapling device.
 9. The surgical stapling device of claim 5, wherein the clamp member has a base having opposed laterally extending flats that are positioned to engage the resilient projections in the pre-actuated state.
 10. The surgical stapling device of claim 9, wherein the base of the clamp member includes proximal stop members positioned at a proximal portion of the laterally extending flats.
 11. The surgical stapling device of claim 1, wherein clamp member defines a threaded bore, and the surgical stapling device further includes a threaded drive member, the threaded drive member being received within the threaded bore such that rotation of the threaded drive member causes axial movement of the clamp member.
 12. A surgical stapling device comprising: an elongate body; and a tool assembly supported on a distal portion of the elongate body, the tool assembly including a cartridge assembly and an anvil assembly that are movable in relation to each other between spaced and approximated positions, the cartridge assembly including a staple cartridge supporting a plurality of staples, a clamp member having a body supporting a knife, and an actuation sled having first and second spaced cam members, the first and second spaced cam members defining a channel there between, each of the first and second spaced cam members including an inner cam member and an outer cam member, each of the inner cam members including a flexible portion supporting an inwardly extending protrusion, the flexible portion being flexible laterally to allow the clamp member to move proximally from within the channel to a position proximal of the channel.
 13. The surgical stapling device of claim 12, wherein the inwardly extending protrusions extend into the channel to obstruct movement of the clamp member within the channel.
 14. The surgical stapling device of claim 13, wherein the inwardly extending protrusions have tapered distally facing surfaces.
 15. The surgical stapling device of claim 12, wherein in a pre-actuated state of the surgical device, the clamp member is positioned within the channel of the actuation sled with the knife of the clamp member positioned distally of a proximal end of the first and second cam members of the actuation sled, wherein during at least a portion of a firing stroke of the surgical stapling device, the clamp member is movable to position the knife proximally of the first and second cam members.
 16. The surgical stapling device of claim 12, wherein the staple cartridge defines a longitudinal axis, a central knife slot extending along the longitudinal axis, and outer and inner cam slots positioned on each side of the central knife slot, wherein outer and inner cam members are received in the outer and inner cam slots, respectively.
 17. The surgical stapling device of claim 16, wherein in a pre-actuated state of the surgical stapling device, the inner and outer cam members of the actuation sled extend beyond the proximal end of the inner and outer cam slots such that the inner and outer cam members are angled outwardly in a direction away from the central knife slot to a position misaligned with the longitudinal axis of the staple cartridge.
 18. The surgical stapling device of claim 16, wherein the actuation sled includes a cross-member interconnecting a distal end of the inner cam members to each other.
 19. The surgical stapling device of claim 18, wherein the surgical stapling device is movable through a firing stroke, the firing stroke including a first advancement stage in which a distal surface of the clamp member is positioned to engage the cross-member of the actuation sled to advance the actuation sled distally within the tool assembly.
 20. The surgical stapling device of claim 19, wherein the firing stroke includes a retraction stage in which the clamp member moves proximally from within the channel into engagement with the inwardly extending protrusions on the flexible portions of the inner cam members to move the flexible portions to the misaligned position and allow the clamp member to move out of the channel of the actuation sled.
 21. A surgical stapling device comprising; a tool assembly including a cartridge assembly and an anvil assembly that are movable in relation to each other between spaced and approximated positions, the cartridge assembly including a staple cartridge supporting a plurality of staples, a clamp member having a body supporting a knife, and an actuation sled having a first portion and a second portion, each of the first and second portions of the actuation sled defining a cam member, the second portion of the actuation sled spaced from the first portion of the actuation sled to define a channel between the first and second portions, the actuation sled having resilient engagement members that are depressed by the clamp member in a first stage, the clamp member being disposed within the channel in the first stage, the resilient engagement members being expanded into the channel in a second stage, the clamp member being disposed proximal of the resilient engagement members in the second stage.
 22. The surgical stapling device of claim 1, wherein the first and second portions of the actuation sled are physically separated from each other. 